510(k) K082356 ยท DYB Introducer, Catheter
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Aug 28, 2008 |
| Received | Aug 18, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082356
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.